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Rbl015.2

This article discusses a clinical trial investigating the use of BNT113, a novel drug, in combination with pembrolizumab for patients with advanced head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses PD-L1. The study aims to compare this combination therapy with pembrolizumab alone in terms of safety, tolerability, and effectiveness in treating this specific type of cancer.

Table of Contents

What is BNT113?

BNT113 is an investigational drug being developed for the treatment of a specific type of head and neck cancer. It is a concentrate for dispersion for injection, which means it’s a liquid medication that needs to be diluted before being administered intravenously (through a vein)[1]. The drug contains two active substances, known as RBL015.2 and RBL016.2, which are classified as nucleic acids – molecules that carry genetic information[1].

Target Condition: HPV16-Positive Head and Neck Cancer

BNT113 is being studied for the treatment of head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16) and expresses a protein called PD-L1[1]. This specific type of cancer can affect various parts of the head and neck, including the:

  • Oropharynx (part of the throat behind the mouth)
  • Oral cavity (mouth)
  • Hypopharynx (lower part of the throat)
  • Larynx (voice box)

The cancer being targeted in this study is considered unresectable (cannot be completely removed by surgery), recurrent (has come back after treatment), or metastatic (has spread to other parts of the body)[1].

How BNT113 Works

While the exact mechanism of action is not fully described in the provided information, BNT113 is being studied in combination with another drug called pembrolizumab. Pembrolizumab is an immunotherapy drug that helps the body’s immune system recognize and fight cancer cells[1]. The combination of BNT113 and pembrolizumab is being investigated to see if it can provide better outcomes for patients compared to pembrolizumab alone.

Clinical Trial Overview

The clinical trial for BNT113 is a Phase II randomized trial, which means it’s testing the drug’s effectiveness and safety in a larger group of patients after initial safety studies have been completed. The trial has two parts[1]:

  1. Safety run-in phase (Part A): This part assesses the safety and tolerability of BNT113 when combined with pembrolizumab.
  2. Randomized phase (Part B): This part compares BNT113 plus pembrolizumab to pembrolizumab alone to see if the combination improves overall survival and tumor response.

Eligibility Criteria

To participate in this trial, patients must meet certain criteria. Some key eligibility factors include[1]:

  • Age 18 or older
  • Confirmed HPV16-positive head and neck squamous cell carcinoma
  • Cancer that expresses PD-L1
  • No prior systemic therapy for recurrent or metastatic disease
  • Measurable disease according to specific criteria
  • Adequate organ function

There are also several factors that would exclude a patient from participating, such as certain medical conditions or prior treatments.

Potential Benefits

The main goals of this study are to determine if BNT113, when combined with pembrolizumab, can[1]:

  • Improve overall survival (how long patients live)
  • Increase the proportion of patients whose tumors shrink or disappear (objective response rate)
  • Extend the time before the cancer progresses (progression-free survival)
  • Prolong the duration of response in patients whose tumors do shrink

Safety Considerations

As with any investigational treatment, there are potential risks and side effects. The trial closely monitors for[1]:

  • Treatment-emergent adverse events (side effects that occur during treatment)
  • Serious or severe side effects
  • Side effects that may require dose adjustments or discontinuation of treatment

Patients considering participation in this trial should discuss potential risks and benefits thoroughly with their healthcare provider.

Aspect Details
Trial Type Phase II, open-label, randomized
Study Drug BNT113 in combination with pembrolizumab
Comparator Pembrolizumab monotherapy
Target Population Patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1
Primary Objectives Assess safety, tolerability, and overall survival
Secondary Objectives Evaluate anti-tumor activity, progression-free survival, and objective response rate
Key Inclusion Criteria Age ≥18 years, confirmed HPV16+ HNSCC, PD-L1 expression, no prior systemic therapy for recurrent/metastatic disease
Key Exclusion Criteria Pregnancy, active infections, certain autoimmune diseases, prior immunotherapy
Primary Endpoints Treatment-emergent adverse events, overall survival, objective response rate

FAQ

  • What is the purpose of this clinical trial? The trial aims to assess the safety, tolerability, and effectiveness of BNT113 combined with pembrolizumab compared to pembrolizumab alone in treating HPV16+ head and neck cancer that expresses PD-L1.
  • Who is eligible to participate in this trial? Eligible participants are adults (18 years or older) with confirmed recurrent or metastatic HPV16+ head and neck squamous cell carcinoma that expresses PD-L1 and is considered incurable by local therapies.
  • What are the main objectives of the trial? The main objectives are to evaluate the safety and tolerability of the combination therapy, and to determine if it improves overall survival and tumor response rates compared to pembrolizumab alone.
  • How is the trial structured? The trial has two parts: a safety run-in phase (Part A) to assess the safety and tolerability of the combination therapy, and a randomized phase (Part B) to compare the effectiveness of the combination therapy with pembrolizumab alone.
  • What are some key exclusion criteria for the trial? Key exclusions include pregnancy, breastfeeding, recent major surgery, active infections, certain autoimmune diseases, and prior treatment with specific immunotherapy agents or systemic anticancer therapy for recurrent or metastatic disease.

Ongoing Clinical Trials on Rbl015.2

  • A study comparing BNT113 combined with pembrolizumab versus pembrolizumab alone for patients with HPV16-positive head and neck cancer that cannot be removed by surgery

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Hungary +5

Glossary

  • Head and Neck Squamous Cell Carcinoma (HNSCC): A type of cancer that begins in the flat cells that line the moist surfaces inside the head and neck regions, such as the mouth, nose, and throat.
  • Human Papillomavirus 16 (HPV16): A specific type of human papillomavirus that is associated with an increased risk of certain cancers, including some head and neck cancers.
  • PD-L1: A protein found on some cancer cells that helps them evade the immune system. Some cancer treatments target this protein to help the immune system recognize and attack cancer cells.
  • Pembrolizumab: An immunotherapy drug that helps the immune system recognize and fight cancer cells by blocking the PD-1 pathway.
  • BNT113: An investigational drug being studied in combination with pembrolizumab for the treatment of HPV16+ head and neck cancer.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, version 1.1 – a standard way to measure how well a cancer patient responds to treatment.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. http://clinicaltrials.eu/trial/study-of-bnt113-and-pembrolizumab-for-patients-with-hpv16-head-and-neck-cancer-expressing-pd-l1/